Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery

Not Applicable

Recruiting

• Conditions: Skin Cancer; Basal Cell Carcinoma
• Interventions: Procedure: MMS + Autologous patch; Procedure: MMS and secondary intention healing

• Registration Number: NCT05170035
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-27
• Study Start: 2022-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Subjects undergoing MMS for biopsy verified primary nodular basal cell carcinoma in the face, head and neck area on a location suitable for secondary intention healing and thus may also be suitable for autologous patch healing
2. Presenting relevant medical record report at study initiation
3. Written informed consent obtained from subject
4. Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation.

Exclusion Criteria

1. A subjects with major systemic disease not yet stabilized
2. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
3. Pregnant or breast feeding
4. Unable to follow the outlined study protocol
5. Participation in other studies at the same time that may affect the wound healing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMS + Autologous patch	MMS + Autologous patch	Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch.
MMS + Secondary intention healing	MMS and secondary intention healing	Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing

Primary Outcome Measures

Name	Time	Method
Blinded assesment of wound healing at day 18-20.	Day 18-20	Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.

Secondary Outcome Measures

Name	Time	Method
Blinded assesment of wound healing at day 11-13	day 11-13	Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no.
Difference in microbiology between intervention wounds and control wounds.	day 1 and day 11-13	Swab test for microbiome analysis will be conducted at day 1 and day 11-13.
Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up.	6 months	The POSAS observer scores scar components with regards to: Vascularity, pigmentation, thickness, surface area, relief and pliability. The collected sum of scores will range from minimum 6 points to maximum 60 points.
TEWL measurement	day 11-13 and day 18-20	Trans epidermal water loss (TEWL) will be meassured at day 11-13 and day 18-20. The TEWL will be meassured on the wound healing site and the contralateral site of the patient's face as a control.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark